MDR Is Here. So What Now?
For the past four years, the medtech world has been on its toes, sometimes nervously, in anticipation of the European Medical Device Regulation (MDR). The application of the MDR would place more onus on all parties (manufacturers, notified bodies, and all other economic operators) to ensure that the product delivered into the market was clinically reliable in terms of usability, safety, and performance. The shift from demonstrating product conformity against directives to adhering to the legally binding regulation has been the cause for great concern within the industry, given the exhaustive nature of the 123 article-long MDR (compared to only 23 articles for its predecessor, MDD).
What's more, the global pandemic delayed the application date of the MDR by one year (to the delight of many). In a previous article, I discussed some details about transitioning to the MDR and provided a simple timeline. Now that it's been one week since the inevitable May 26 D-Day, the MDR is officially the new legal document that regulates medical devices in the EU market. There is no going back, for now. There are certainly mixed emotions about the MDR, but we can't ignore the benefits of having a harmonized regulatory system. Whether the MDR achieves such benefits will be a matter of time. In my opinion, we'll have a good sense of this by the end of 2021.
So what should you do now? Well, it depends. Before I present a few scenarios, let's talk about one of the biggest concerns so far. To date, according to the NANDO (New Approach Notified and Designated Organisations) database, there are only 20 notified bodies that are MDR-compliant and can issue new CE certificates. Unfortunately, this number has increased very slowly: only two new notified bodies have been added to the NANDO list since December 2020. At this rate, we will only have 22 notified bodies by the end of 2021. In other words, getting an MDR-ready notified body is one of the most critical steps in getting your device to the EU market.
Here are five scenarios that may apply to you:
You have a new product, and you don't have an EC certificate yet: In this case, you need to find out if your notified body is MDR-compliant and listed in the NANDO database. If not, you will have to find an MDR-compliant one. You will then prepare technical documentation (Annex II of MDR) and undergo a conformity assessment by the notified body in question.
Your EC certificate was issued under the MDD (or AIMDD) but is expiring after the date of application of the MDR: If your EC certificate expires after 26 May 2021, you will have to get MDR certification when the certificate expires. The same steps mentioned in scenario 1 are applicable.
Your EC certificate was issued under the MDD (or AIMDD) but is expiring after the date of application of the MDR. You would like to make design changes to your device: If you would like to release a new version of your device, and there are major design changes, you will require recertification under the MDR. In this case, the steps mentioned in scenario 1 are applicable.
You have recently renewed your EC certificate (before 26 May 2021) under the MDD (or AIMDD), and your device is in circulation/distribution in the EU market: You may continue to make your device available on the market until 26 May 2025 or until the EC certificate expires, whichever comes first. Once the certificate is due for renewal, the steps in scenario 1 are applicable.
You are a manufacturer based outside the EU region: If you are in a non-Member State, you can still sell into the EU market, provided that you get an authorised representative as per the requirements of Article 11 of the MDR.
In my previous article on Transitioning to the MDR, I mentioned that the clock was ticking. That time has now passed and the MDR ball is rolling. While several new guidance documents are being published by the MDCG (Medical Device Coordination Group), if any of the scenarios (or a combination) apply to your organization, you need to get started as soon as possible. The MDR may not be perfect or anywhere close to what the industry may have wanted, but it is the only gateway to the EU market. The sooner we try to implement it, the better.
If you need assistance with MDR technical documentation, pre-conformity assessments, or authorized representative services, contact us. Additionally, if you are looking for a smart, paperless solution for your ISO 13485 QMS, book a demo to find out how we can help you digitize your system.